A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformi
- Conditions
- E10Insulin-dependent diabetes mellitus-E10 Insulin-dependent diabetes mellitus
- Registration Number
- PER-106-09
- Lead Sponsor
- sanofi-aventis Recherche & Development,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Patients with type 2 diabetes mellitus, as defined by CMS (WHO) (I), diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with metformin at a stable dose of at less 1.5 g / day for at least 3 months prior to the selection visit. In addition to metformin, patients may receive sulfonylureas (these should be suspended at visit I) and / or thiazolidinediones (this can be continued).
• Obtain informed written consent
• In the age of selection • In the selection HbA1c <7.0 or HbA1c> 10%
• Pregnancy or breastfeeding
• Women with reproductive capacity without effective contraceptive method.
• Type 1 diabetes mellitus
• Metformin not in a stable dose of at least 1.5 g / day for at least 3 months prior to the selection visit.
• Use of oral or injectable or hypoglycemic antidiabetic agents other than metformin, sulfonylurea and thiazolidinediones (eg alpha glucosidase inhibitor, other GLP-1 receptor agonists, DPP-IV inhibitors, insulin etc.) within 3 months prior to At the time of selection, use of medications to lose weight if they are not at a stable dose for at least 3 months prior to the selection visit.
• History of ignorance of hypoglycemia.
• Body Mass Index (BMI) <20 kg / m2
• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach / gastric surgery, inflammatory bowel disease
• History of metabolic acidosis, including ketoacidosis within 1 year prior to selection
• Hemoglobinopathy or hemolytic anemia, blood transfusion or plasma products within 3 months prior to the date of selection
• Within the last 6 months prior to selection: a history of myocardial infarction, attack or heart failure requiring hospitalization
• Known history of drug or alcohol abuse within 6 prior to the time of selection
• Any clinically significant abnormality identified in the physical examination, laboratory tests, ECG or vital signs at the time of selection that, in the opinion of the investigator or some sub-investigator, could impede the completion of the study safely or restrict the evaluation of efficacy, such as major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema that would probably require laser treatment within the study period.
• Hypertension not controlled or inadequately controlled at the time of selection with resting systolic or diastolic blood pressure> 180 mmHg or> 110 mmHg, respectively
• Patients considered by the investigator or some sub-investigator as inappropriate for this study for any reason (eg, inability to meet the specific requirements of the protocol, such as scheduled visits, who are able to self-inject, who are prone to require treatment during the selection phase and treatment phase with drugs not allowed by the clinical study protocol, that the patient is the researcher or some sub-researcher, pharmacist, study coordinator, other study staff or relative from this directly involved in the protocol conduction, etc).
• Use of systemic glucocorticoids (excluding topical application or inhaled forms) for a week or more within 3 months prior to the time of selection
• Use of any investigational medication within 3 months prior to selection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.<br><br>Measure:Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24<br>Timepoints:Baseline, Week 24<br>
- Secondary Outcome Measures
Name Time Method